Randomized, Placebo-controlled Homeopathic Drug-proving of SARS CoV-2 nosode (BiosimCovex) in healthy volunteers

Abstract

Introduction The Homeopathic Pathogenetic Trial (HPT, Drug-proving) is a systematic examination and recording of the symptoms experienced by healthy volunteers after an administration of an investigational medicinal substance. Randomized, placebo-controlled HPT was conducted using BiosimCovex (SARS CoV-2 nosode) in healthy volunteers.  Materials and methods BiosimCovex 30c was given orally in a randomized, placebo-controlled trial to examine the safety and pathogenetic effects of 30 volunteers (18- 65 years of age and both genders). Volunteers were administered a dose of 6 pills of the nosode once a day for two weeks followed by 30 days observation period. Pre and post-examination (physical), vital signs, and laboratory investigations were done with a run-in period of 7 days. Symptoms experienced by the volunteers were recorded and analyzed, and Qualitative and Quantitative indices per volunteer were reported. Trial registered at http://ctri.nic.in (CTRI/2022/06/043392). Results BiosimCovex nosode exhibited quantitatively distinct symptoms, which can be applied in clinical practice. The number of symptoms reported in the verum arm was 73 (placebo 11). The incidence of the Pathogenetic effect per volunteer in the verum group was 8.1 vs that of the placebo 5.5. The Qualitative Pathogenetic Index was 0.295 in the verum group as compared to the placebo 0.193. The symptoms observed matched with the symptoms produced in an open-label Phase 1 study conducted during the COVID-19 pandemic and also with that of the viral infection. There were no serious/fatal adverse events during the study. Safe use was documented. Conclusion BiosimCovex nosode developed during a pandemic condition produced specific symptoms in the homeopathic pathogenetic trial which could be used in clinical practice.